Haematology Analytical Performance Specifications
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| Measurand | Lower limit | Upper limit |
|---|---|---|
| WCC | + or - 0.5 ≤ 5.0 x109/L | + or - 10% > 5.0 x109/L |
| RCC | + or - 0.2 ≤ 2.0 x1012/L | + or - 10% > 2.0 x1012/L |
| Hb | + or - 5 ≤ 100 g/L | + or - 5% > 100 g/L |
| Hct | + or - 0.04 ≤ 0.20 | + or - 20% > 0.20 |
| MCV | + or - 5 ≤ 50 fL | + or - 10% > 50 fL |
| MCH | + or - 2 ≤ 20 pg | + or - 10% > 20 pg |
| MCHC | + or -30 ≤ 300 g/L | + or - 10% > 300 g/L |
| RDW-CV | + or - 2 ≤ 10% | + or - 20% > 10% |
| PLT | + or - 25 ≤ 100 x109/L | + or - 25% > 100 x109/L |
| MPV | + or - 2 ≤ 10 fL | + or - 20% > 10 fL |
| Measurand | Lower limit | Upper limit |
|---|---|---|
| PT | + or -2.0 ≤ 10.0 sec | + or - 20% > 10.0 sec |
| INR/POC INR | + or - 0.3 ≤ 2.0 ratio | + or - 15% > 2.0 ratio |
| APTT | + or - 10 ≤ 40 sec | + or - 25% > 40 sec |
| Fibrinogen | + or - 0.20 ≤ 1.0 g/L | + or - 25% > 1.0 g/L |
| Thrombin Time | + or - 3 ≤ 12 sec | + or - 25% > 12 sec |
| Factor II, V, VII, VIII, IX, X, XI, XII | + or - 3 ≤ 10 IU/dL | + or - 30% > 10 IU/dL |
| D-Dimer (Automated) | + or - 0.25 ≤ 0.50 DD mg/L | + or - 50% > 0.50 DD mg/L |
| D-Dimer (Automated) | + or - 0.5 ≤ 1.0 FEU mg/L | + or - 50% > 1.00 FEU mg/L |
| Measurand | Lower limit | Upper limit |
|---|---|---|
| Hb A2 | + or - 0.3 ≤ 2.0% | + or - 10% > 2.0% |
| Hb F | + or - 0.5 ≤ 1.50% | + or - 30% > 1.50% |
| Hb Variant | + or - 4 ≤ 20% | + or - 20% > 20% |
| Measurand | Lower limit | Upper limit |
|---|---|---|
| WCC | + or - 0.5 ≤ 5.0 x109/L | + or - 10% > 5.0 x109/L |
| Neutrophils/Granulocytes | + or - 1.0 ≤ 10.0% | + or - 10% > 10.0% |
| Lymphocytes | + or - 2.0 ≤ 10.0% | + or - 20% > 10.0% |
| Monos/Eosinos/Basos/LUC/IG | + or - 3.0 ≤ 10.0% | + or - 30% > 10.0% |
| Measurand | Lower limit | Upper limit |
|---|---|---|
| APTT | + or - 9.0 ≤ 30 sec | + or - 30% >30 sec |
| APTT Screen Ratio | + or - 0.3 ≤ 0.9 ratio | + or - 30% > 0.9 ratio |
| DRVVT screen | + or - 9.0 ≤ 30 sec | + or - 30% > 30 sec |
| DRVVT screen ratio | + or - 0.3 ≤ 0.9 ratio | + or - 30% > 0.9 ratio |
| Measurand | Lower limit | Upper limit |
|---|---|---|
| Protein C functional | + or - 12 ≤ 60% | + or - 20% > 60% |
| Protein S Total Antigen | + or - 10 ≤ 40% | + or - 25% > 40% |
| Protein S Free Antigen | + or - 10 ≤ 40% | + or - 25% > 40% |
| Protein S Free Functional | + or - 10 ≤ 40% | + or - 25% > 40% |
| AT Functional | + or - 10 ≤ 40% | + or - 25% > 40% |
| Measurand | Lower limit | Upper limit |
|---|---|---|
| APCR APTT, APCR APTT V, APCR RVVT, APCR RVVT V, APCR Staclot | Assessed on interpretation | Assessed on interpretation |
| Measurand | Lower limit | Upper limit |
|---|---|---|
| FVIII:C | + or - 3 ≤ 10% | + or - 30% > 10% |
| VWF:Ag | + or - 3 ≤ 10% | + or - 30% > 10% |
| VWF:RCo | + or - 4 ≤ 10% | + or - 40% > 10% |
| VWF:CB | + or - 4 ≤ 10% | + or - 40% > 10% |
| VWF:Activity | + or - 4 ≤ 10% | + or - 40% > 10% |
| Measurand | Lower limit | Upper limit |
|---|---|---|
| Inhibitor level BU | Assessed on interpretation | Assessed on interpretation |
| Measurand | Lower limit | Upper limit |
|---|---|---|
| Closure time | Assessed on interpretation | Assessed on interpretation |
| Measurand | Lower limit | Upper limit |
|---|---|---|
| APTT | + or - 10 ≤ 40 sec | + or - 25% > 40 sec |
| Anti Xa | + or - 0.1 ≤ 0.4 U/mL | + or - 25% > 0.4 U/mL |
| Measurand | Lower limit | Upper limit |
|---|---|---|
| DTI | + or - 25 ≤ 100 ng/mL | + or - 25% > 100 ng/mL |
| Measurand | Lower limit | Upper limit |
|---|---|---|
| Anti Xa | + or - 25 ≤ 100 ng/mL | + or - 25% > 100 ng/mL |
| Measurand | Lower limit | Upper limit |
|---|---|---|
| Anti Xa | + or - 25 ≤ 100 ng/mL | + or - 25% > 100 ng/mL |
| Measurand | Lower limit | Upper limit |
|---|---|---|
| Factor XIII | Assessment on diagnostic interpretation | Assessment on diagnostic interpretation |
| Measurand | Lower limit | Upper limit |
|---|---|---|
| G6PD assay | + or - 3.0 ≤ 10.0 U/g Hb | + or - 30% > 10.0 U/g Hb |
| Measurand | Lower limit | Upper limit |
|---|---|---|
| ESR | + or - 3.0 ≤ 10.0 mm/hr | + or - 30% > 10.0 mm/hr |
| Measurand | Lower limit | Upper limit |
|---|---|---|
| Percentage | + or - 0.6 ≤ 2.0% | + or - 30% > 2.0% |
| Absolute count | + or - 21.0 ≤ 70.0 | + or - 30% > 70.0 x109/L |
| Measurand | Lower limit | Upper limit |
|---|---|---|
| Percentage | + or - 1.0 ≤ 10.0% | + or - 10% > 10.0% |
| Absolute count | + or - 10 ≤ 100 | + or - 10% > 100 x109/L |
| Measurand | Lower limit | Upper limit |
|---|---|---|
| Clotting Times | Assessment under review | Assessment under review |
| Measurand | Lower limit | Upper limit |
|---|---|---|
| Clotting Times | Assessment under review | Assessment under review |
| Measurand | Lower limit | Upper limit |
|---|---|---|
| %CD34 | + or - 0.05 ≤ 0.20% | + or - 25% > 0.20% |
| Total CD34 | + or -5 ≤ 20.0 | + or - 25% > 20.0 μL |
